Kruse Controls, Inc. has been providing validated automation systems for the pharmaceutical and biotechnology industries for years.

Our automation systems typically utilize programmable logic controllers (PLCs) for logic control. We have, however, utilized direct PC control when requested by the customer and where it made sense. Our systems often utilize human-machine interface (HMI) products to provide operators with control and monitoring capabilities. We have designed automation systems for a diverse group of applications, including:

	Raw material batching systems
	Continuous process control systems
	Clean In Place (CIP) systems
	Recipe management systems
	Inventory management
	Line integration and control
	Packaging equipment control and integration
	Quality control and inspection systems
	Downtime tracking systems

Where dynamic batch recipe control and extensive batch archiving were required, we have provided ISA S88 compliant batching systems using off-the-shelf products customized for the specific application.

Where data acquisition and storage were required, we provided database servers and I/O structures to gather process information and store it in reliable and efficient tables. Automatic report generation via printers, email or intranet is provided when required.

At Kruse Controls, Inc. , we are familiar with the cGMP guidelines required for FDA validation. Our design and implementation process allows us to provide well-documented systems that can be easily validated for the FDA. We have passed customer audits that examined our design and documentation procedures to help ensure future validation success.

The recent FDA emphasis on 21 CFR Part 11  compliance places a premium on companies with control, data handling and validation compliance experience. Kruse Controls, Inc. is experienced in all these areas and has helped several customers meet 21 CFR Part 11  compliance. Kruse Controls, Inc. can provide 21 CFR Part 11  compliance audits, recommend and implement 21 CFR Part 11  compliance strategies and provide validation for 21 CFR Part 11  compliant systems.

Part 11 Compliance Auditing

	Computer System Assessment
	Infrastructure Assessment (Network Topology)
	Plant Floor Automation Systems Assessment
	Software Assessment
	Code and Documentation Assessment

Part 11 Compliance Strategies

	Develop In House Compliance Team
	Training on Part 11
	Define Critical Operations and Associated Systems
	Develop In House Standards (Consider Corporate Global Harmony)
	Develop a Compliance Plan

Part 11 System Development (Life Cycle Methodology)

	System Replacement or Remediation?
	Develop User Requirements
	Develop Functional Specs
	Audit Potential Vendors
	Select Hardware and Software
	Develop Traceability Matrix

Project Implementation (Life Cycle Methodology)

	Design Based on Functional Spec and GxP
	Design Review
	Implement Design following GMP
	Functional Testing
	Stress Testing
	Software and Hardware Maint. Documents
	User's Manual
	Qualification and Validation
	Training

Part 11 Additional Services

	Change Control Computer and PLC Programming
	Calibration, Testing and Software/Hardware Validation
	Spreadsheet and Macro Part 11 Compliance Development
	Traceability Matrix Development (Verifies system conforms to User and Functional Specs)

Whether you require validated full-scale production automation, validated data collection or 21 CFR Part 11  expertise, Kruse Controls, Inc. can be your sole source solution.